The UA Division of Trauma, Critical Care and Emergency Surgery has received a grant of $1.7 million to take part in a study trial that will determine which type of blood transfusion is the most beneficial for trauma patients.
The study, known as Pragmatic, Randomized Optimal Platelet and Plasma Ratios, will employ the University of Arizona and 12 other Level 1 trauma centers across the nation to look at the two most common types of blood transfusions over a three-year period to determine which one is most effective.
The two blood combination ratios that will be compared consist of a ratio of one unit of red blood cells, one unit of plasma and one unit of platelets, and a ratio of two units of red blood cells, one unit of plasma and one unit of platelets, said Terence O’Keeffe, associate professor of surgery and medical director of the Surgical/Trauma Intensive Care Unit, who will also be leading the study.
Both combinations have been used before, but not in a way that compares the two ratios to evaluate the effectiveness each has on patients, he added.
During a regular blood donation, blood is taken away as a whole from the person and separated into red blood cells, plasma and platelets, said Deborah Novak, assistant professor of pathology and director of Transfusion Medicine. Through the separation, physicians are able to tell what type of blood supplies are present, Novak said.
Whole blood is separated into different components in the case that a patient might need only one component instead of whole blood, O’Keeffe added.
“What we try to do is take all those components and try to reconstitute them in the patient as a whole again,” O’Keeffe said.
If the blood is left as a whole component, the blood unit gets coagulated, yet when it is separated each component serves as a purpose, Novak said.
“Most of the research that is being done in this area suggests that patients do better when they are given more blood,” O’Keeffe said. “What we don’t know is whether we should give patients just complete reconstituted whole blood ratio of one-to-one or if we can get away with giving a little less.”
Although, when whole blood gets divided and is put together again, it’s not exactly whole blood anymore, Novak said. When the components get separated they are slightly altered with preservatives and nutrient solutions to keep them in good condition, she said.
A total of 580 patients will be enrolled in the study throughout all 12 participating centers. UA Medical Center is projecting to enroll 44 patients. Twenty-two randomized patients will be given the 1-to-1-to-1 ratio and the other 22 patients will be given the 1-to-1-to-2 ratio.
“We are not changing practice, in a way we are trying to figure out which one it is,” O’Keeffe said. “We are making things possibly better for patients.”
If patients do not want to take part in the study, they can request to opt-out and will be given a red bracelet that indicates the patient declined to take part in the research. Patients have to be at least 15 years of age, weigh at least 110 pounds and will typically be in critical condition, according to O’Keeffe.
The PROPPR trial follows the U.S. Food and Drug Administration regulation, which allows the researchers to enroll patients in the study if there is a life-threatening risk. Therefore, patients who are traumatically injured and cannot consent to being part of the study will be enrolled in the study.
The procedure will last between 18 to 24 months and the rest of the time will be spent on writing the research results. Patients will not be kept in the hospitals after the trial, and depending on the patient’s condition, will be discharged if their health has improved, O’Keeffe said.
Any trauma surgeon who is on call during the trial can be involved in taking care of the patient, but they will not be focusing on the research, he added.
O’Keeffe also said that being chosen to participate in the study helps show how the UA is progressing in the area of medical research.
“I think it’s extremely exciting that the UA has been chosen to be involved in this research,” he said. “It shows that we are moving forward in medical research and it is reassuring that we can be involved in cutting edge research on the clinical side.”
The UAMC will not be the first to begin the trial within the 12 centers, but the 12 participating centers are the first ever to be conducting this study, Novak said.
“I am honored to be able to work with them [researchers],” Novak said. “This is great for the UA campus that we have been selected to participate in this study. It speaks to the level of quality care that we provide here.”
UAMC has been chosen to be part of the 12 participating centers based on the institution having highly visible contribution and the diverse reputation that the research department has received over the years, said Rainer Gruessner, chief of the UA Department of Surgery.
“I am not surprised that we have been selected,” Gruessner said. “I think it’s an honor to be part of this study. This study will have an impact on the future and how we will treat patients on the surgery on a large amount of blood loss.”
